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| Name | Class |
|---|---|
| C&R Research, Inc. | INDUSTRY |
| CRScube | UNKNOWN |
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The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.
GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC6101A 37.5mg | Experimental | Administer 12.5mg of GC6101A t.i.d for 2 weeks. |
|
| GC6101A 75mg | Experimental | Administer 25mg of GC6101A t.i.d for 2 weeks. |
|
| GC6101A 150mg | Experimental | Administer 50mg of GC6101A t.i.d for 2 weeks. |
|
| Placebo | Placebo Comparator | Administer placebo t.i.d for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC6101A 37.5mg | Drug | Administer 12.5mg of GC6101A t.i.d for 2 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy | The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions] | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A percentage of subjects showed significant improvement of stomach erosions by the endoscopy | The definition of "significant improvement" is the subject showed score changed from 2-4 to 1. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions] | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Min Kim, B.S. | Contact | +82-31-260-1936 | dreamerkdm@greencross.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyo Jin Park, MD, Ph.D | Yonsei University, Gangnam Severance Hospital of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University, Busan Paik Hospital of Korea | Recruiting | Busan | South Korea |
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| GC6101A 75mg |
| Drug |
Administer 25mg of GC6101A t.i.d for 2 weeks. |
|
| GC6101A 150mg | Drug | Administer 50mg of GC6101A t.i.d for 2 weeks. |
|
| Placebo | Drug | Administer placebo t.i.d for 2 weeks |
|
| A percentage of subjects showed improvement of edema rating scale |
The definition of "improvement" is the subjects showed score changed from 2 to 1. |
| 2 weeks |
| A percentage of subjects showed improvement of erythema rating scale | The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more. | 2 weeks |
| A percentage of subjects showed improvement of hemorrhage rating scale | The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more. | 2 weeks |
| A percentage of subjects showed improvement of gastric symptom rating scale | The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more. | 2 weeks |
| Adverse Events | 2 weeks |
| Lab results(Hematology, Blood chemistry, Urinalysis) | 2 weeks |
| The results of physical examinations and Vital signs(body temperature, pulse) | 2 weeks |
| EKG results | 2 weeks |
| Keimyung University, Dongsan Medical Center of Korea | Recruiting | Daegu | South Korea |
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| Wonkwang University, Hospital of Korea | Recruiting | Iksan-si | South Korea |
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| Seoul National University, Bundang Hospital of Korea | Recruiting | Seongnam-si | South Korea |
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| Chungang University, Hospital of Korea | Recruiting | Seoul | South Korea |
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| Ewha Womans University, Medical Center of Korea | Recruiting | Seoul | South Korea |
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| Inje University, Seoul Paik Hospital of Korea | Recruiting | Seoul | South Korea |
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| Kankbuk Samsung Medical Center of Korea | Recruiting | Seoul | South Korea |
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| Korea University, Guro Hospital of Korea | Recruiting | Seoul | South Korea |
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| Seoul National University, Hospital of Korea | Recruiting | Seoul | South Korea |
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| Soonchunhyang University, Seoul Hospital of Korea | Not yet recruiting | Seoul | South Korea |
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| The Catholic University, Seoul St. Mary's Hospital of Korea | Recruiting | Seoul | South Korea |
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| Yonsei University, Gangnam Severance Hospital of Korea | Recruiting | Seoul | South Korea |
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| Ajou University, Medical Center of Korea | Recruiting | Suwon | South Korea |
|
| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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